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Browse Drug Recalls

1,392 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,392 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 1,392 FDA drug recalls in 2022.

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DateProductReasonClassFirm
Jun 23, 2022 NPX TRIPLE ANTIBIOTIC OINTMENT 1 OZ SKU 910320 NPX PAIN ITCH SCAR ANTIBAC O... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 PREFERRED URINRY PN RLF MAX STRNGTH 12 CT distributed to specific Family Doll... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 DRX FIBER CAPSULES 100 CT distributed to specific Family Dollar Stores 04/30/... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 PREVACID 24HR LANSOPRAZOLE 15MG CAP 14CT distributed to specific Family Dolla... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 MEDIC EYE DROPS MAX REDNESS SKU 998920 CLR EYS MX RDNS RLIF 0.5 FL OZ SKU 9... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 ST IVES BLKHD CLRNG GREEN TEA SCRUB 6 OZ SKU 2007787 AMBI EXFOLIATING WASH 5... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 CLARITIN ALLERGY LIQ CHLDRNS GRAPE 2 FLOZ SKU 900834 CLARITIN ALLERGY 10MG T... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 RIC STOOL SOFTENER SOFTGEL 100 CT SKU 917000 RIC STOOL SOFTNER 100 CT SKU 9... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 DIAL MENS EUCALYPTUS AB BODY WASH 20 FLOZ SKU 2096030 distributed to specific... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 BENADRYL EXTRA STRENGTH CREAM 1 OZ distributed to specific Family Dollar Stor... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 VICKS VAPOCOOL DROPS SEVERE 18 CT SKU 999488 BEST HEALTH HONEY LEMON COUGH ... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 ARTHRITIS HOT CREME 3 OZ SKU 901452 ICY HOT PATCH 1 CT SKU 911030 ICY HOT... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 AZO YEAST PLUS 20 CT distributed to specific Family Dollar Stores 04/30/2022 ... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 FLEET GLYCERIN SUPPOSITORIES 50 CT distributed to specific Family Dollar Stor... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 ZARBEES NTRL CHLD COUGH MUCUS GRP 4 FL OZ distributed to specific Family Doll... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 READY IN CASE MICON 7 DAY 1.59 OZ SKU 939212 READY IN CASE MICON 3 DAY COMB... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 SWAN PETROLEUM JELLY 7.5 OZ SKU 910721 BABY LOVE PETROLEUM JELLY 13 OZ SKU ... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 READY IN CASE RUBBING ALCOHOL 91 PCT 16 FL OZ SKU 902270 READY IN CASE 70 ... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 BC POWDER 50 CT SKU 901588 BC POWDER 18 CT SKU 913228 GOODYS POWDER 50 CT... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 CARMEX DAILY CARE CHERRY SPF 15 0.35 OZ SKU 901842 CARMEX LIP BALM JAR 0.25... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 DESITIN CREAMY OINTMENT 2 FL OZ SKU 912976 BABY LOVE OINTMENT CREAM 4 OZ SK... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 EXCEDRIN MIGRAINE CAPLET 24 CT distributed to specific Family Dollar Stores 0... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 GOOD SENSE SORE THROAT SPRAY CHERRY 6 FL OZ distributed to specific Family Do... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 QP COLD MULTI SYMPTM DAY NITE CPLT 24 CT distributed to specific Family Dolla... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 QP SUDFEDRINE PE MAX STRENGTH TBLT 24 CT distributed to specific Family Dolla... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 GS ANTI DIARRHEAL LOPERAMIDE CAPLET 12 CT SKU 915632 IMODIUM AD MINT 4 OZ SK... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 SWAN POVIDONE 4 FL OZ distributed to specific Family Dollar Stores 04/30/2022... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 ZZZQUIL NIGHT PAIN BERRY 12 FL OZ distributed to specific Family Dollar Store... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 DOCTOR DANDRUF 2N1 SHAMP CLN APL 13.5FLOZ SKU 2005726 SUAVE 2N1 MENS CC ANT... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 DR SCHOLLS ANTI FUNGAL SPRAY PWDER 4.7 OZ SKU 998250 PREMIER ANTFGL TLNFTT ... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 NPX ENEMA 4.5 FL OZ 2 PK distributed to specific Family Dollar Stores 04/30/2... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 VICKS DAYQUIL NYQUIL LIQ COMB PK 6 FLOZ distributed to specific Family Dollar... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 NICORETTE GUM WHITE ICE MINT 4 MG 20 CT distributed to specific Family Dollar... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 ROBITUSSIN COUGH N CHEST CONGESTION 4 FL OZ SKU 919471 DELSYM ORANGE 3 FL O... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 QP MOTION SICKNESS TABLET 8 CT distributed to specific Family Dollar Stores 0... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 BANANA BOAT SPRT CLR SPRY SPF50 6 FL OZ SKU 2007524 SUNTONE SPORT SPRAY SPF ... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 MIRALAX 8.3 OZ distributed to specific Family Dollar Stores 04/30/2022 throug... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 SWAN CALAMINE LOTION 6 FL OZ distributed to specific Family Dollar Stores 04/... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 QP LAXATIVE BISACODYL 5 MG TABLET 50 CT SKU 902449 QP WOMEN LAXATIVE BISCOD... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 PEPCID COMPLETE CHEWABLE TAB BERRY 8CT SKU 903365 PEPCID AC MAXIMUM STRENGT... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 GUARDIAN ANTACID EX STRGTH TBLT FRT 96CT SKU 901379 GUARDIAN CHWABLE SMTHIE... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 DR SCHOLLS CLR AWAY LIQ WART REMVR 20CT SKU 998384 DR SCHOLLS CALLUS REMOVE... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 AMBI NRSHNG DAILY FACIAL MSTURZER 1.7 OZ distributed to specific Family Dolla... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 QP COUGH COLD TABLET 16 CT distributed to specific Family Dollar Stores 04/30... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 21, 2022 Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsu... Superpotent Drug: Out of specification for assay at the 12-month timepoint. Class III SUN PHARMACEUTICAL INDUSTRIES INC
Jun 21, 2022 Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-d... cGMP - Water leakage Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jun 21, 2022 Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsul... Superpotent Drug: Out of specification for assay at the 12-month timepoint. Class III SUN PHARMACEUTICAL INDUSTRIES INC
Jun 17, 2022 Morphine Sulfate extended-Release Tablets, USP; 30 mg, 100-count bottles, Rx ... Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets conta... Class I Bryant Ranch Prepack, Inc.
Jun 17, 2022 Morphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx ... Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets conta... Class I Bryant Ranch Prepack, Inc.
Jun 16, 2022 Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC ... Defective Container Class III Glenmark Pharmaceuticals Inc., USA

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.